Thorough and detail-oriented Quality Assurance Director with 15+ years of experience in quality/compliance functions including development and management of quality systems, auditing, and investigating complaints and issuing corrective and preventative functions. Demonstrates success in maintaining compliance, developing strategies to manage issues, and leading initiatives to facilitate internal and external process and enhance efficiency. Excellent client relationship management.CORE COMPETENCIES*Exceptional leader that influences teams and effectively communicates and negotiates with management and key clients; confident in speaking and delivering ideas.*Conduct thorough analyses of systems to provide troubleshooting and recommending course of action when issues arise to save time and maximizing efficiency. *Consistently builds and maintains rapport with management, teams, and clients by bringing value, integrity, and creative ways to maintain compliance. *Self-starter with the ability to work independently; analytical and strategic in prioritizing responsibilities and planning with a strong attention to detail, time management, organization, and ability to multitask especially under strict deadlines. *Expertise in a broad range of industry guidelines and regulations and policies and procedures with adherence to standards, ensuring compliance, and maintaining business perspective*Excellent team managment and CMO management skills with many years of relationship building and problem solving.
Listed skills include Gmp, Capa, 21 Cfr Part 11, Pharmaceutical Industry, and 9 others.